There has been a flurry of good books recently on the state of psychiatry, more specifically on the proliferation of “syndromes” over the past several decades, and the vast increases in people being prescribed drugs for these – including ever larger numbers of children. Marcia Angell had two excellent pieces in The New York Review of Books a year or so ago: “The Epidemic of Mental Illness: Why?” and “The Illusions of Psychiatry”. These reviewed the following: Unhinged: The Trouble with Psychiatry – A Doctor’s Revelations about a Profession in Crisis, by Daniel Carlat; Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, by Robert Whitaker; and The Emperor’s New Drugs: Exploding the Antidepressant Myth, by Irving Kirsch.
Now comes one of the single best summations of what is terribly wrong with our current system of health: an article in The Guardian by psychiatrist Ben Goldacre called “The Drugs Don’t Work: A Modern Medical Scandal.” It’s long but very worth reading in full.
What Goldacre’s piece is so good at is making clear just how corrupt the process is by which new drugs become approved for sale. For example, most people are not aware that negative test results simply don’t need to be published, and rarely are. Goldacre begins with an experience he’d had prescribing the antidepressant Reboxetine. He’d read the published studies (the results of the trials were “overwhelmingly positive”), talked it over with his patient, and they went ahead. However, two years ago a much bigger picture emerged when researchers were able to locate and collect all the data on this particular drug. It turns out that out of seven trials comparing it to a placebo, only one of these showed a positive result. And this, of course, was published. The other six trials, making use of nearly 10 times the number of patients, showed the drug worked no better than a sugar pill.
These were never published.
The story is the same with studies comparing Reboxetine to other antidepressants. And it’s the same with studies on side effects.
Here is Goldacre’s summary of the current state of affairs:
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.
In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.
Goldacre includes a disturbing example of a dangerous drug (Rosiglitazone) remaining on the market for years because the system is so flawed. The trouble is: nothing changes in this regard. There has been a record number of fines imposed upon the pharmaceuticals in recent years but even though the amounts seem high to us, they represent a non-constraining fraction of annual profits. So there is simply no incentive to be safer; every incentive to cut corners, spin results, and find new “markets”…